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FDA Approves Rasuvo (Subcutaneous Methotrexate) for Treatment of Arthritis and Psoriasis

Product will be available in 10 dosage strengths

The FDA has approved Rasuvo, a subcutaneous injectable methotrexate therapy, for the treatment of patients with rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA), or psoriasis. The product will be available in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5-mg increments.

The product’s developer (Medac Pharma) concurrently announced that the U.S. District Court for the District of Delaware has denied a motion for a preliminary injunction filed by Antares Pharma, Inc.

With more than 30 years of clinical use, methotrexate is the most commonly used drug for treating RA and is recommended by both the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) as a first-line therapy for RA patients.

While many patients prescribed methotrexate receive an oral form of the drug, this route of administration has been associated with highly variable absorption rates and inconsistent bioavailability among patients, according to Medac. The subcutaneous mode of delivery of Rasuvo was designed to improve bioavailability.

Methotrexate inhibits dihydrofolic acid reductase, thereby interfering with DNA synthesis, repair, and cellular replication. Actively proliferating tissues, such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder, are generally more sensitive to this effect of methotrexate. The mechanism of action of methotrexate in RA is unknown; it may affect immune function.

Rasuvo (subcutaneous methotrexate) is a folate analog metabolic inhibitor indicated for the management of patients with severe, active RA or pJIA who are intolerant of or had an inadequate response to first-line therapy. Rasuvo is also indicated for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. It is not approved for the treatment of neoplastic diseases.

Clinical trials in patients with RA were performed using other formulations of methotrexate. In patients with RA, effects of methotrexate on articular swelling and tenderness could be seen as early as 3 to 6 weeks. Most studies of methotrexate in patients with RA were relatively short (3 to 6 months). Limited data from long-term studies have indicated that an initial clinical improvement is maintained for at least 2 years with continued therapy.

Clinical trials in patients with pJIA were performed using other formulations of methotrexate.

In a 6-month, double-blind, placebo-controlled study of 127 pediatric patients with pJIA (mean age, 10.1 years; range, 2.5 to 18 years; mean duration of disease, 5.1 years) receiving background nonsteroidal anti-inflammatory drugs and/or prednisone, methotrexate given weekly at an oral dose of 10 mg/m2 provided significant clinical improvement compared with placebo, as measured by either the physician’s global assessment or a patient composite (i.e., 25% reduction in the articular severity score plus improvement in parent and physician global assessments of disease activity).

The labeling for Rasuvo includes a boxed warning regarding the potential for severe toxic reactions, including embryo-fetal toxicity and death.

Sources: Medac Pharma; July 14, 2014; and Rasuvo Prescribing Information; July 2014

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